Cleared Traditional

K121429 - AIMAGO EASYLDI MICROCIRCULATION CAMERA

K121429 is an FDA 510(k) clearance for AIMAGO EASYLDI MICROCIRCULATION CAMERA, manufactured by Aimago SA. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K121429 · Aimago SA · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
88d
Days
Class 2
Risk

K121429 is an FDA 510(k) clearance for the AIMAGO EASYLDI MICROCIRCULATION CAMERA. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Aimago SA (Lausanne, CH). The FDA issued a Cleared decision on August 10, 2012 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K121429

510(k) Number K121429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2012
Decision Date August 10, 2012
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPT Probe, Blood-flow, Extravascular

All 47
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K121429 · AIMAGO EASYLDI MICROCIRCULATION CAMERA
Download PDF FDA Summary Aimago SA